7 Clinical Trials for Various Conditions
This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA® Redensity with new anesthetic agent is non-inferior to RHA® Redensity with lidocaine in terms of injection site pain felt by the subject during injection. At screening, the Principal Investigator (PI) evaluated subjects' perioral rhytid severity (using the Perioral Rhytid Severity Rating Scale; PR-SRS) to confirm eligibility and to establish a pre-treatment score for assessing aesthetic improvement. At Visit 1, RHA® Redensity with new anesthetic agent was administered in a random sequence (first or second injection) and side of the mouth (left or right) and RHA® Redensity with lidocaine was administered to the other side. Study subjects and the PI injecting study devices were blinded. Immediately after injection of an upper perioral quadrant, subjects rated the injection site pain experienced during injection using a 100 mm Visual Analog Scale (VAS). Injection site pain in each side of the mouth was also assessed at 15, 30, 45 and 60 minutes after injection of the upper quadrant. Safety evaluation consisted of AE assessments, a 30-day CTR (Common Treatment Response) diary and a follow-up call performed by the study site at 72 hours after injection. Subjects attended Visit 2 (30 days post-injection) where effectiveness and safety assessments were conducted. Subjects who presented with an unresolved clinically significant device related AE at Visit 2 received a optional follow-up phone call no later than 30 days after Visit 2. If the clinically significant AE remained unresolved, the Investigator requested that the subject attended the optional in-clinic follow-up visit (i.e., Visit 3) within 5 working days. Follow-up of the clinically significant AE continued until the AE was resolved or the TI determines that additional follow-up was not necessary.
This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA® Redensity with new anesthetic agent is non-inferior to RHA® Redensity with lidocaine in terms of injection site pain felt by the subject during injection. At screening, the Treating Investigator (TI) evaluated subjects' perioral rhytid severity (using the Perioral Rhytid Severity Rating Scale; PR-SRS) to confirm eligibility and to establish a pre-treatment score for assessing aesthetic improvement. At Visit 1, RHA® Redensity with new anesthetic agent was administered in a random sequence (first or second injection) and side of the mouth (left or right) and RHA® Redensity with lidocaine was administered to the other side. Study subjects and the TI injecting study devices were blinded. Immediately after injection of an upper perioral quadrant, subjects rated the injection site pain experienced during injection using a 100 mm Visual Analog Scale (VAS). Injection site pain in each side of the mouth was also assessed at 15, 30, 45 and 60 minutes after injection of the upper quadrant. Safety evaluation consisted of AE assessments, a 30-day CTR (Common Treatment Response) diary and a follow-up call performed by the study site at 72 hours after injection. Subjects attended Visit 2 (30 days post-injection) where efficacy and safety assessments were conducted. Subjects who presented with an unresolved clinically significant device related AE at Visit 2 received a optional follow-up phone call no later than 30 days after Visit 2. If the clinically significant AE remained unresolved, the Investigator requested that the subject attended the optional in-clinic follow-up visit (i.e., Visit 3) within 5 working days. Follow-up of the clinically significant AE continued until the AE was resolved or the TI determines that additional follow-up was not necessary.
Randomized, blinded, No-Treatment control, multi-center, prospective clinical study, to identify whether TEOSYAL RHA® Redensity is more effective than No-Treatment in the correction of moderate to severe dynamic perioral rhytids at Week 8 after last treatment (i.e., initial or touch-up treatment). The Treating Investigator (TI) at screening will evaluate the subject's perioral rhytids severity using the Perioral Rhytids Severity Rating Scale (PR-SRS) for eligibility of the subject for the study. The Blinded Live Evaluator (BLE) at screening will evaluate the subject's perioral rhytids severity using the PR-SRS in order to confirm eligibility and to establish a pre-treatment (Baseline) score for assessment of effectiveness. This is done independently of the TI, and exact concordance between the BLE and the TI is not necessary for eligibility of the subject in this study. Enrolled subjects will be randomized to either the TEOSYAL RHA® Redensity treatment group or the "No-Treatment" control group (ratio 3:1). The TI will administrate the study device, and if necessary, subjects will receive a touch-up treatment 14 days following the initial treatment to optimize the results. The TI will conduct safety and effectiveness evaluations at study visits, which occurred at Week 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment. The Blinded Live Evaluator (BLE) will conduct assessments of effectiveness during the trial, including assessment of the primary endpoint at Week 8 after the last treatment (i.e., initial or touch-up treatment). The BLE will conduct effectiveness evaluations at Week 8, 12, 16, 24, 36, and 52 after the last treatment (i.e., initial or touch-up treatment). All subjects will be followed for 52 weeks after the last treatment (i.e., initial treatment or touch-up), at which point they will be offered Repeat-Treatment (provided that the TI deems the treatment to be appropriate and the subject agrees) and will be then followed for 4 weeks after Repeat-Treatment before exiting the study. If a subject returns to his pre-treatment PR-SRS score at Week 12 or Week 16 or Week 24 or Week 36 after initial treatment or touch up (as assessed by the TI), subjects are eligible for optional Early-Retreatment if necessary at 12 or 16 or 24 or 36 weeks after last treatment (provided that the TI deems the treatment appropriate, and the subject agrees). Subjects will be then followed for an additional 4 weeks after Repeat-Treatment. Subjects who will receive optional Early-Retreatment at Week 12 or Week 16 or Week 24 or Week 36 after the after initial treatment or touch-up, will be offered Repeat-Treatment at Week 52. Subjects randomized to the "No-Treatment" control group will receive their first treatment after the primary endpoint evaluation (Week 8 after randomization) and then will be followed the same schedule as the initial treatment group.
Perioral rhytides present a difficult problem in facial rejuvenation. They cannot be addressed with rhytidectomy (face lift) and direct excision can leave visible unfavorable scars. Currently, fine static wrinkles are most effectively treated with facial resurfacing, usually with laser treatment. Often the peri-oral area is treated with additional spot treatments with an ablative laser to cause a more robust healing response and better aesthtic result. To date, no studies have specifically shown efficacy of additional spot treatment over full facial laser alone. This study is designed as a split-face study, to compare the aesthetic results of full field laser resurfacing on one half of the face with that of spot treatment of perioral rhytides on the other half. To clarify further to the IRB board, this is not an experimental treatment. Spot treatment is used by many surgeons/laser proceduralists for addressing specific areas of the face. This is an FDA indicated use of the laser for facial resurfacing. Due to the many genetic and enviromental factors that can effect the results the best design for the study to is have each patient serve as their own control with a split-face study.
This will be a single-center, randomized, evaluator-blinded, split-face clinical study design. Fifty patients will receive one treatment session consisting of Restylane® Silk (right side of the face) and Belotero Balance® (left side), or vice versa (1:1 dose conversion ratio) injections to the superficial, vertical perioral lines. Injections will be performed at the baseline visit. To ensure subject and investigator blinding, syringes will be prepared and labeled "1" and "2" immediately before subject attendance for injection by the sub-investigator. The same injection sites and techniques will be used on both sides of the face. Then, patients will follow-up on post-treatment day 7, 14, 30, 60, 90, 120, 150, 180.
This is a multi-center, open-label, single-arm study to assess the safety of an injection technique with Restylane Silk in lip augmentation and correction of perioral rhytids .
Open-label, non-randomized, prospective, multi-center, self-controlled